- Getting Started: Your Introduction to Clinical Research (CTSA1):In this introductory course, attendees will receive an overview of topics relevant to clinical research, including Federal entities and regulations, the Institutional Review Board (IRB), study start-up, subject enrollment, informed consent, reporting requirements and Good Clinical Practice. This course is intended for staff and investigators who are new to clinical research.
- Informed Consent Process (CTSA2):This course will take the student through the step-by-step process of obtaining subject informed consent. This includes discussing the elements of informed consent, documenting the informed consent process, and ensuring proper informed consent processes can be followed.
- CTRC Overview and Height/Weight/Vitals Signs Competency Training (CTSA3):In this course, attendees will observe the correct methods for obtaining height, weight, and vital signs (blood pressure, temperature, pulse, and respirations) from adult patients. Attendees can also participate in a walking tour of both the inpatient and outpatient UCH CTRCs. The tour will include an overview of the process for scheduling patients; where specific CTRC patient procedures take place (e.g., blood collection, ECHO, and EKG); and coordinator work space in the clinic.
- Overview of Human Subjects Regulations (CTSA6):This training will provide an introduction to human subjects research regulations; the differences between Exempt, Expedited, and Full Board reviews; and an introduction to human subject research involving vulnerable populations.
- Clinical Trial Design (CTSA7):This course provides insight into how and why clinical trials are designed the way they are. Topics include defining the study population, common characteristics, key aims of phases, randomization, blinding, and outcomes analysis. This course is perfect for people who have worked in clinical trials and want to better understand the science behind the method, or anyone who is considering designing a clinical trial.
- Submitting to COMIRB (CTSA8):In this training, participants will learn step-by-step instructions for filling out the COMIRB application and the attachments.
- Writing Informed Consents (CTSA9):This training will cover considerations and regulations for the entire consent process. Participants will also be introduced on how to translate the protocol into a consent form at or below an 8th grade reading level and how to check for missing pieces.
- IRB Responsibilities After Initial Approval (CTSA10):This training will review the reporting responsibilities of the PI once the study has been initially approved by COMIRB. It will include how to submit unanticipated problems, amendments, and continuing review requirements.
- Recruitment and Retention of Study Subjects (CTSA11):This training will cover the steps involved in recruitment, discuss national studies that have had high enrollment and retention rates, and the regulations surrounding recruitment. Also included will be a section on recruiting protected and special populations.
- Clinical Trial Conduct - Study Start-Up (CTSA12):This course is perfect for coordinators and investigators who want to better understand how to start a clinical trial from the perspective of the Sponsor, the FDA, the IRB, and the study site. Topics covered include, but are not limited to: how to get selected as a site for a trial; how to develop a recruitment plan; and a discussion about what regulatory documents are required to start a trial (includes a hands-on FDA Form 1572 exercise). Learning objectives: understand the activities during the start-up of a clinical trial and practice relevant site activities conducted during start-up of a clinical trial.
- Clinical Trial Conduct - Enrollment (CTSA13):This course is perfect for coordinators and investigators who want to better understand the enrollment phase of a clinical trial from the perspective of the Sponsor, the FDA, the IRB, and the study site. Topics covered include, but are not limited to: informed consent process (including a hands-on exercise); implementing protocols (including a hands-on exercise); and creating and maintaining appropriate study documentation. Learning objectives: understand the activities during the enrollment phase of a clinical trial and practice relevant site activities conducted during the enrollment of a clinical trial.
- Clinical Trial Conduct - Participant Follow-Up and Close-Out (CTSA14):This course is perfect for coordinators and investigators who want to better understand the participant follow up and close out phases of a clinical trial from the perspective of the Sponsor, the FDA, the IRB, and the study site. Topics covered include, but are not limited to: adverse events and serious adverse events (including a hands-on exercise); responding to data queries (including a hands-on exercise); and close-out monitoring visits. Learning objectives: understand and practice activities for participant follow up and close out phases of a clinical trial.
- How FDA and COMIRB Interact (CTSA17):This course will provide students with an overview of both FDA and COMIRB requirements and expectations following initial approval of a clinical trial project. This course will cover continuing reviews, adverse event reporting, and protocol amendments.
- Preparing for FDA Audits (CTSA18):This course will provide the participant with a practical understanding of what to expect before, during, and after an FDA audit. A review of common findings and FDA Form 483 content will be covered.
- Budgeting for Clinical Trials (CTSA19): This training will cover the steps needed to create a clinical trial budget, thinking through what needs to be included, and how to check for overlooked items.
- Research Billing and Compliance (CTSA20):This course will cover topics associated with insurance billing compliance and law. This course can assist investigators to ensure correct billing of items and services associated with research to a third-party payer or to the research account. This is an essential course if your clinical research involves University of Colorado Hospital space and/or patients.
- Human Gene Transfer: Submitting to the Institutional Bio-safety Committee (CTSA21):This course will provide an overview of requirements for submitting to the IBC. In addition, this course will help you to understand what studies require IBC review/approval and why.
- Conflict of Interest (CTSA23):This course provides the participant with an overview of current regulations--both Federal and local--governing COI and clinical trial conduct.
- Export Control, What is a "Deemed Export" (CTSA24): This course provides the participant with an overview of current regulations--both Federal and local--governing export control.
- Quality Improvement or Research? (CTSA25): This course will take the student through the background and process for determining whether a project is Quality Improvement or Human Subjects Research including regulatory definitions of “human subjects” and “research” and what to consider when the project could be either.
- Medical Device Regulatory Paths and Clinical Trials (CTSA26): This course walks coordinators and investigators through the complex pathways by which devices are investigated and approved, including IDE and IDE exemption, 510k and PMA approvals.